Psychiatric Drug Withdrawal is an Adverse Drug Reaction

Federal law recognizes that psychiatric drug withdrawal is an adverse drug reaction. According to, 21 U.S. Code § 355–1 an adverse drug experience is defined as “any adverse event associated with the use of a drug in humans, whether or not considered drug related, including:

(A) an adverse event occurring in the course of the use of the drug in professional practice;
(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
(C) an adverse event occurring from abuse of the drug;
(D) an adverse event occurring from withdrawal of the drug; and
(E) any failure of expected pharmacological action of the drug.”

For more than 20 years, World-wide media has reported about adverse effects of psychiatric drugs including suicidal ideation, homicidal ideation, mania, paranoia, delusions, psychosis, worsening depression and/or anxiety, and more. Yet, it is not widely known that withdrawal from the drugs include equally severe effects. This is one reason why it is vital to always consult and work with a qualified physician when considering to taper off a mental health drug.

Psychiatric Drug Withdrawal is an Adverse Drug Reaction and so are the horrific results of one’s actions while on the drug, even if the drug was prescribed by a doctor. Adverse events are classified as such and statistics are monitored throughout the world, yet this doesn’t help the millions of individuals and families who suffer as a result of the adverse reactions. Unfortunate as this is, it can be prevented with the use of medical testing.

According to the FDA report, Preventable Adverse Drug Reactions: A Focus on Drug Interactions, “ADRs are one of the leading causes of morbidity and mortality in health care. The Institute of Medicine reported in January of 2000 that from 44,000 to 98,000 deaths occur annually from medical errors.1 Of this total, an estimated 7,000 deaths occur due to ADRs. To put this in perspective, consider that 6,000 Americans die each year from workplace injuries.”

More currently, and according to a medical journal report, written by Xiao-Wu Chen, Wanging Liu and Shu-Feng Zhou “

Adverse drug reactions (ADRs) are one of the major causes of patient morbidity and mortality”, and that “A meta-analysis of 39 prospective studies from hospitals in the United States suggests that approximately 6.7% of hospitalized patients have serious ADRs and 0.32% of them have fatal reactions, and thus there are probably more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 per year in the US [1]. This figure appoints ADRs between the 4th and 6th leading causes of death in patients.” This article continues by relaying the long-known information about genetic testing. Testing that can be done prior to anyone ever taking a drug, revealing the likelihood of the person experiencing an adverse reaction. This test is available to the public and unfortunately most people don’t know it exists and, therefore, do not know to ask there doctor for this test prior to taking the prescribed drug. The medical report states that, “There are numerous factors which contribute to the occurrence of ADRs and variation in drug responses in different individuals. Some of these factors include patient age, sex, body weight, nutrition, organ function, infections and co-medications. Also, poor prescribing behaviour, for example, prescribing inappropriate doses in the presence of a contraindication or co-prescribing two drugs with a potential interaction may also result in an ADR. “

Important to note, that despite removing these factors, “a substantial proportion of ADRs remain present due to a genetic predisposition. It has become evident in recent years that genetic factors may also significantly alter drug responses or increase the risk for ADRs.”

Psychiatric drug withdrawal is considered an adverse effect and can be reported to the FDA. More importantly, working with a non-mental health doctor to get the genetic testing prior to taking any mental health drug, can possibly save lives.

Federal Law:

Pharmacogenomics-Guided Approaches to Avoiding Adverse Drug Reactions